Georgia Compounding Factory Recalls Sterile Products
FDA is alerting health care providers that a Georgia compounding pharmacy has recalled all of its sterile products distributed in the United States since October 19, following reports of serious eye infections, the agency said on Thursday. Until further notice, health care providers should stop using all sterile products distributed by Clinical Specialties Compounding and […]
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PDF Problems Reported With FDA’s New eCopy Rule
March 24, 2013 In the last 10 days, we have been reporting on some of the problems and confusion surrounding the new eCopy program by FDA. You can read our other reports on eCopy here, here and here. In eCopy, the agency seems to have a belief that PDFs are an open format that one […]
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The Death of Paper – FDA eCopy
March 24, 2013 The date Dec. 30, 2012 was a big one for regulatory. This was the last day that you could submit a major application just on paper. In its place is the new eCopy system just finalized by FDA in January. According to what we have been hearing from industry, many people are […]
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Inspection report details ongoing problems at Hospira
The FDA earlier this month dashed the hopes of Hospira ($HSP) that its Rocky Mount, NC, plant was finally out of the woods when it handed executives a 21-page inspection report detailing 20 observations, many of them with multiple points. During the company’s earnings call in February, CEO F. Michael Ball said the company was […]
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Servier Scandal Sucks in French Regulator
May 7 – FDA Recalls on the Rise – How to Design a Bulletproof Recall Strategy The scandal over a Servier Laboratories diabetes pill, which has been blamed for at least 500 deaths in France, has now ensnared the French regulatory agency. The ANSM has come under formal investigation for alleged involuntary manslaughter over concerns […]
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Congress Crack Down on Prescription Painkillers
Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission In the latest move to crack down on abuse of prescription painkillers, a bill has been introduced in Congress that would move medications that contain hydrocodone, such as Vicodin, to to a more restrictive ranking on the national law enforcement schedule. Specificaly, […]
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Georgia compounding pharmacy recalls sterile products – FDA
FDA is alerting health care providers that a Georgia compounding pharmacy has recalled all of its sterile products distributed in the United States since Oct. 19, following reports of serious eye infections, the agency said on Thursday. Recall Tips According to Former FDA Recall Chief Until further notice, health care providers should stop using all […]
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More Tips to Survive Your FDA Clinical Inspection
March 22, 2013 We sat down last week with Dennis Moore, the president of AUK Technical Services. Dennis was an FDA investigator for more than 15 years and has some interesting perspectives on FDA clinical inspections, to say the least! He also provided some great tips on regular FDA inspections. Make sure that you always […]
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FDA Recall Strategy Tips
March 25, 2013 We recently had the opportunity to chat with Rita Hoffman, who currently is the managing partner of RHoffman, Inc. She has more than 35 years of FDA experience in drugs, devices and veterinary products. Until 2010, she was the recall branch chief for CDRH. She gave us some useful FDA recall tips […]
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Danger! Beware of Legal Landmines in Your Company’s Records
March 21, 2013 If you ever wondered how a record in your pharmaceutical company can be a ‘landmine,’ Nancy Singer has the answer. She teaches an unusual, in person seminar called Dangerous Documents: Avoiding Land Mines in Your Emails and FDA Records. According to Singer, the term ‘land mine’ is a term for a possibly […]
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